This invention relates to a device made from segmentally demineralized and appropriately shaped and machined bone for implantation as a ligament, tendon, support or in any other application in which an implant having at least one rigid segment and at least one flexible segment, is required.
There is a continuing need in the art for biologically acceptable ligament or tendon replacements. Various efforts have been made in the art to accommodate this need. For example, in U.S. Pat. No. 5,053,049, a flexible prosthesis of predetermined shape and a process for making said prosthesis was disclosed. According to that disclosure, a flexible biocompatible and non-antigenic prosthesis for replacement of a cartilaginous part was prepared by machining bone into a desired shape corresponding to the shape of a cartilaginous body part to be replaced, demineralization of the bone to impart flexibility, and tanning to reduce antigenicity. There was no disclosure or suggestion of using the demineralized bone as a tendon or ligament replacement.
In U.S. Pat. No. 5,092,887, a method for replacement or augmentation of a damaged fibrous connective tissue was disclosed wherein a ligament made from a segment of bone that had been demineralized was attached between first and second body parts. There was no disclosure or suggestion of machining the bone prior to demineralization to produce fixation ends thereon, and demineralization of only a segment of the thus machined bone to produce a flexible segment, while leaving the machined attachment ends in a fully mineralized and rigid state for fixation directly to bone adapted to receive such fixation ends. The disclosure in the U.S. Pat. No. 5,092,887 with respect to its discussion of background art and methods of demineralization of bone is hereby incorporated by reference.
This invention provides a novel bone implant having at least one rigid, mineralized bone segment, which may be machined to include threads, grooves, a driver head, a recess or a symmetric or asymmetric shape, and at least one flexible, demineralized segment, which may also be machined to any desired shape prior to demineralization, or after demineralization.